| 上海富纯中南生物技术有限公司成立于2002年6月,是上海市高新技术产业,并以开发具有自主知识产权的新型基因重组药物和诊断产品为主的研发型生物技术公司。在致力于引进国际先进技术的同时,注重研究项目的产业化和技术创新。公司成立以来,成功的从英国剑桥大学引进了人-人杂交瘤技术,从美国引进了组织芯片技术、兔杂交瘤技术、蛋白复性技术等国际先进技术,并在此技术平台的基础上研发出自己的产品。公司承担了多项包括国家“863”计划、上海市重大攻关项目及浦东新区科技专项资金政府课题,申请了十余项发明专利。 公司拥有从基因表达技术,蛋白表达与制备,抗体研究和生物制剂药效学研究的专业化实验室,建有符合GMP标准的蛋白药物中试实验室和符合ISO标准并通过国家质量管理体系考核的诊断试剂生产车间。能够满足新药申报和诊断试剂生产的场地和设备要求。 公司的研究开发力量强大,目前公司下属科研部、治疗产品部和诊断试剂部三个部门。主要负责人有丰富的生物医药行业管理和产品开发经验,已成功完成过数个生物类新药的研发与申报。公司共有员工三十多人,大部份研发人员具有博士、硕士学位。 公司首席科学家倪健博士于1991年毕业于剑桥大学,获博士学位,以主要作者先后在国际著名学术刊物如Cell,Nat Med,Nat Immunol,Science等杂志上发表论文82篇,影响因子共计595.8,论文SCI引用的次数超过4000次。1996年在Cell上发表的有关FLICE的工作,被Science杂志评为1996年10大科学突破之一。据不完全统计,在HGS发表的两百多篇文章中,有1/4左右以他为主要作者;HGS获美国专利局批准的四百个左右的专利中,有1/4左右由他发明;HGS从人类基因组研究中得到的8项在临床试验的产品中,有6项基于他的专利。倪健去年被评为上海市基因组药物和抗体组药物专业的优秀学科带头人,上海市政府科学预见专家,也是自1978年以来六大部委首次评选出的“全国留学人员先进个人”, 并获国家杰出青年科学基金,负责国家863计划重大专项主课题、上海科委重大招标课题等多项研究课题。 公司副总经理兼技术总监杨子义1994年毕业于中国协和医科大学,北京协和医院获医学博士学位。1994年在军事医学科学院基础医学研究所博士后流动站做博士后。任北京免疫学会秘书长,中国人民解放军专业技术委员会免疫专业组秘书长。承担并顺利完成国家“七 .五”、“八.五”攻关计划课题。1994.12~1996.12 从事噬菌体显示技术确定抗体识别表位的研究工作,负责完成国家教委博士后基金和院青年基金。在国家“863”计划的课题随机肽库确定功能性抗体表位及探索多肽新药结构,和国家自然科学基金免疫学重点课题疾病相关抗体表位的确定两项课题中作为分题负责人。1999.01~2003.05 任生物技术研究室主任,军队新药审评专家委员会委员。完成400平方米包括细胞培养、蛋白纯化、制剂制备、无菌分装与冻干、成品检验等条件中试实验室的建设。负责多项科技风险投资基金资助的新药研究项目和中试放大、工业产业化设计和技术转让培训等任务。 Founded in June 2002, Shanghai Fuchun-Zhongnan Biotech Co., Ltd. is a research-based Biotech Company that focuses on R&D innovative gene recombination biological products and diagnostic kits. From its foundation, The company has introduced successfully human-human Hybridoma monoclonal antibody technology from University of Cambridge, tissue array technology and protein refolding technology from USA. Based on the technology, the company develops its own products. The company has acquired respectively several funds from the Science and Technology Commission of Shanghai Municipality (STCSM), Hi-tech R&D Program of China (863) and Nature Science Fund of China, and applied for more than 10 patents. The company is comprised of scientific research department, therapeutic drug department and diagnostic reagent department. Several bio-pharmaceuticals are relate to many fields such as diseases of bone and arthritis, thrombosis-form diseases, chronical obstructive pulmonary diseases and tumor therapy, some of them have been finished pre-clinical research and are applied for clinical trial now. Some diagnostic kits about autoimmune disease (AID) and other bio-markers which are researched and applied for now will come into the market recently.
This highly gifted, rapidly expanding team has more than 30 members. Over about ten members own doctor degree and master degree. among which are several outstanding experts who were directly involved in development and commercialization of biotech products with abundant experience and knowledge on management and development in the field. The company has established four major R&D platforms combined with standardization process, including gene clone, protein expression and purification, antibody research and bio-pharmaceuticals. The company has a pilot scale experiment lab of protein pharmaceuticals R&D which is accord with GMP and a production shop that is ISO13485 certificated by the SFDA for the diagnostic reagent production. It can meet the requirement of bio-pharmaceuticals R&D, application and diagnostic reagent production.
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